- 74.5% of patients achieved a complete response at any time
- Median duration of response is greater than 27 months and not reached
- Latest data update continued to show favorable safety and tolerability results
- Company hosting virtual investor event with lead investigator at 8 am EDT today
“There continues to be a significant need for new treatment options for patients with bladder cancer,” said Gary D. Steinberg, M.D., Professor, Department of Urology at Rush University Medical Center. “Therefore, I am very encouraged by the latest data from the BOND-003 study, which demonstrates cretostimogene’s compelling efficacy as well as its ability to induce a bestin- class durable response in NMIBC patients, with 56.6% of patients remaining in response at 24 months or greater, by K-M estimate. Additionally, 97.3% of patients were free from progression to Muscle Invasive Bladder Cancer (MIBC) at 12 months. If approved by the FDA, cretostimogene may represent an important, bladder-sparing, advancement in the bladder cancer treatment paradigm, and meaningfully improve patient outcomes.”There were no Grade 3 or greater treatment-related adverse events (TRAEs) or deaths reported. No treatment-related discontinuation of cretostimogene was observed. 97.3% of patients completed all expected treatments, demonstrating favorable patient adherence and compliance. The most common TRAEs (≥10%) were bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria.
“The BOND-003 monotherapy data underscores our novel investigational oncolytic immunotherapy’s unique product profile, including its dual mechanism of action, which we believe differentiates it from current and investigational NMIBC treatments,” said Ambaw Bellete, President & Chief Operating Officer, CG Oncology. “Based upon the latest data, we are confident that cretostimogene is well positioned to address an unmet need for patients as a potential backbone bladder-sparing therapeutic if approved by the FDA.”About the BOND-003 Phase 3 Trial BOND-003 (NCT04452591) is a single-arm, Phase 3, monotherapy clinical trial for the treatment of patients with high-risk BCG-unresponsive NMIBC with carcinoma in-situ (CIS) with or without Ta or T1 papillary tumors. The fully enrolled global trial with a total of 112 patients is currently ongoing in North America and the Asia-Pacific region. The primary endpoint of the trial is CR at any time, with DOR measured as a secondary endpoint. The highly pre-treated trial population includes patients with prior intravesical chemotherapy and systemic immunotherapy.
Cretostimogene monotherapy received FDA Fast Track and Breakthrough Therapy Designations in BCG-Unresponsive, high-risk NMIBC patients with CIS in December 2023. On May 3, 2024, CG Oncology presented preliminary data from the Phase 3 BOND-003 trial at the 2024 American Urological Association Annual Meeting.
Source: CG Oncology (2024 Dec 5). Groundbreaking Cretostimogene Grenadenorepvec Monotherapy Data Demonstrates Sustained, Durable Complete Responses in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer [Press Release].
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